This phase II trial studies how well cemiplimab works before surgery in treating patients
with stage II-IV head and neck cutaneous squamous cell cancer that has come back (recurrent)
and can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as
cemiplimab, may help the body's immune system attack the cancer, and may interfere with the
ability of tumor cells to grow and spread.
I. To determine the overall response rate (ORR) using Response Evaluation Criteria in Solid
Tumors (RECIST) version (v)1.1 criteria to neoadjuvant cemiplimab (REGN2810) in patients with
stage II-IV cutaneous squamous cell carcinoma (cSCC) of the head and neck who are planned for
definitive local surgery with or without radiation.
I. To determine the pathologic response rate to neoadjuvant REGN2810 in patients with stage
II-IV cSCC of the head and neck.
II. To determine the safety and tolerability of neoadjuvant REGN2810 in patients with stage
II-IV cSCC of the head and neck who are planned for definitive local surgery and radiation.
III. To estimate the 2-year disease-specific (DSS), disease-free (DFS) and overall survival
(OS) compared to historical controls.
IV. To determine the time to recurrence and patterns of failure. V. To evaluate the effects
of neoadjuvant REGN2810 on the expression of PD-1 and potential related immune regulating
targets in cSCC of the head and neck.
Patients receive cemiplimab intravenously (IV) over 30 minutes every 3 weeks. Cycles repeat
every 3 weeks for up to 6 weeks with or without radiation therapy at the discretion of the
treating physician in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and then
periodically for up to 5 years.
Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck, Stage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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